COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g Paste, Dentifrice
by Colgate-Palmolive Company · 1 TUBE in 1 CARTON (35000-979-86) / 90 g in 1 TUBE
NDC 35000-0979-86
🏷️ FDA NDC (as labeled)
35000-979-86
billing pads the product segment with a zero
This package
Contains90 g in 1 tube
Pack sizes4 compare ↓
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
35000-979-86
Product NDC
35000-979
11-digit billing NDC
35000097986
RxCUI
1038995
UNII
C810JCZ56Q
Application #
M021
SPL Set ID
ed20cf9d-6162-4337-bb0b-1a6a6e9e1dc3
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-10-14
Route
DENTAL
Dosage form
PASTE, DENTIFRICE
Substance
SODIUM MONOFLUOROPHOSPHATE
Why two NDCs?
The FDA registers this code as 35000-979-86 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 35000-0979-86. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Caries prophylactic agents class.
Drug family (ATC)
Caries prophylactic agents, Fluoride
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerColgate-Palmolive Company
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code35000
First marketedOct 2019
Product typeHuman Otc Drug
Portfolio176 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
🧪 What is this product?
This is an over-the-counter toothpaste marketed under FDA's OTC monograph rules for dental care products. Sodium monofluorophosphate is a fluoride compound typically used in toothpastes to help strengthen tooth enamel and reduce the risk of tooth decay. The product is applied topically to the teeth as part of regular oral hygiene.
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about SODIUM MONOFLUOROPHOSPHATE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
White
FlavorMint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
-
UNII X69NU20D19
Calcium pyrophosphate is a mineral salt compound used in medications as a buffering agent and pH regulator. It helps stabilize the medicine and can also serve as a filler to provide bulk to tablets or capsules.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII BBX060AN9V
Hydrogen peroxide is a chemical solution used in medicines as a cleansing agent or preservative. It helps prevent bacterial growth and is sometimes used in oral or topical formulations.
-
UNII JP0CK963E0
A synthetic polymer made from polyethylene glycol and polypropylene glycol chains. It acts as a solubilizer and emulsifier to help dissolve and blend oil and water components in medicines.
-
UNII NL4J9F21N9
Polyethylene glycol 600 is a synthetic liquid polymer used as a solvent and humectant in medicines. It helps dissolve active ingredients and keeps products from drying out.
-
UNII E54VE15114
Povidone K15 is a synthetic polymer made from petroleum-derived materials. It acts as a binder and film-former in tablets and capsules, helping hold ingredients together and improve how the medicine dissolves in your body.
-
398 mg / 1 g
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII H5WVD9LZUD
A mineral salt used in medicines as a buffer to help maintain proper acidity levels and as a texturing agent in solid dosage forms. It helps stabilize the medicine and improve its shelf life.
-
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
-
UNII O352864B8Z
A sodium salt compound used in medicines as a buffering agent to maintain pH stability and as a chelating agent to prevent unwanted chemical reactions during storage and mixing.
-
UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
14 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesPropylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, PEG-12, Glycerin, Flavor, Hydrogen Peroxide, Sodium Lauryl Sulfate, Silica, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Colgate Optic White Pro Series Enamel Renewal Soothing Mint 1.5 mg/g 35000-0791-62 | Colgate-Palmolive | 2 tubes | — | — | FDA listed | — |
| Colgate Optic White Pro Series High Impact White 1.5 mg/g 35000-0792-63 | Colgate-Palmolive | 1 tube | — | — | FDA listed | — |
| Colgate Optic White Advanced Enamel Strength 1.5 mg/g 35000-0921-32 | Colgate-Palmolive | 1 tube | — | — | FDA listed | — |
| Colgate Optic White Advanced Oxygenating White 1.5 mg/g 35000-0933-32 | Colgate-Palmolive | 1 tube | — | — | FDA listed | — |
| Colgate Optic White Advanced Vibrant Clean 1.5 mg/gthis 35000-0979-86 | Colgate-Palmolive | 1 tube | — | — | FDA listed | — |
| Colgate Optic White Pro Series Hi White 1.5 mg/g 65954-0841-63 | Mission | 1 tube | — | — | FDA listed | — |
| Colgate Optic White Pro Series 11.4 mg/g 65954-0845-62 | Mission | 2 tubes | — | — | FDA listed | — |
| Crest 3D White Advanced 1.7 mg/g 69423-0752-30 | The | 1 tube | — | — | FDA listed | — |
| Crest 3D White Brilliance Pro Ultra White 1.7 mg/g 69423-0760-30 | The | 1 tube | — | — | FDA listed | — |
| ARC 2 in 1 Whitening and Anticavity 1.7 mg/g 69423-0837-30 | The | 1 tube | — | — | FDA listed | — |
| Crest 3D White Brilliance Advanced Whitening Fresh Mint 1.7 mg/g 69423-0959-04 | The | 1 cello | — | — | FDA listed | — |
| Hapee Explosive Menthol Red 150 .15 g/100g 1480003401156 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Fresh And Cool White 150 .15 g/100g 1480003401136 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Fresh And Cool White 100 .15 g/100g 1480003401135 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Gumtect Gum Care .15 g/100g 1480003401325 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Fresh Green Outburst 100 .15 g/100g 1480003401165 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Fresh Green Outburst 150 .15 g/100g 1480003401166 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Hapee Outrageous Blue Chill 150 .15 g/100g 1480003401336 | LAMOIYAN | 1 tube | — | — | FDA listed | — |
| Crest 3D White Deep Stain Remover Dazzling Mint 2 mg/g 84126-0610-21 | The | 1 tube | — | — | FDA listed | — |
| Crest 3D White Deep Stain Remover Ultra White 2 mg/g 84126-0611-02 | The | 2 tubes | — | — | FDA listed | — |
| Crest 3D White Brilliance Pro Ultra White 1.7 mg/g 84126-0616-38 | The | 1 tube | — | — | FDA listed | — |
| Crest 3D White Deep Stain Remover Brilliant White 2 mg/g 84126-0626-03 | The | 2 tubes | — | — | FDA listed | — |
| Crest 3D White Deep Stain Remover Enamel Strength 2 mg/g 84126-0644-21 | The | 1 tube | — | — | FDA listed | — |
| Crest Kids Advanced Color Changing 1.5 mg/g 58933-0024-04 | Procter | 1 cello | — | — | FDA listed | — |
| SprinJene Natural 1.5 mg/g 63404-0201-01 | Health | 1 tube | — | — | FDA listed | — |
| SprinJene Health Boost 1.5 mg/g 63404-1108-01 | Health | 1 tube | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SODIUM MONOFLUOROPHOSPHATE — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 28%
Female · 72%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 35000-0979-32 | 1 TUBE in 1 CARTON (35000-979-32) / 127 g in 1 TUBE | 2019-10-14 | Discontinued by firm |
| 35000-0979-76 | 2 TUBE in 1 CARTON (35000-979-76) / 90 g in 1 TUBE | 2019-10-14 | Discontinued by firm |
| 35000-0979-86 You're viewing this | 1 TUBE in 1 CARTON (35000-979-86) / 90 g in 1 TUBE | 2019-10-14 | Active |
| 35000-0979-78 | 1 TUBE in 1 CARTON (35000-979-78) / 70.8 g in 1 TUBE | 2025-02-01 | Active |
Pack size FAQ
What quantity is in NDC 35000-0979-86?
NDC 35000-0979-86 is listed by the FDA — 1 tube in 1 carton / 90 g in 1 tube.
What NDC number is used to bill for this package of COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g Paste, Dentifrice?
Bill NDC 35000-0979-86 — the 11-digit billing format is 35000097986. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 35000-979-86, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 35000-0979-86, written without dashes as 35000097986. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 35000-0979-86, the first segment (35000) is the labeler code FDA assigned to Colgate-Palmolive Company; the middle segment (0979) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (86) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Colgate-Palmolive Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 tube (35000-0979-32), 1 tube (35000-0979-78), 2 tubes (35000-0979-76). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Colgate-Palmolive Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Use helps protect against cavities
⏱️ Dosage and Administration ▾
Directions adults and children 6 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 6 to 12 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 6 years do not use unless directed by a dentist or physician
⚠️ Warnings ▾
Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Active ingredient Sodium Monofluorophosphate 1.14% (0.19% w/v fluoride ion)
🧪 Inactive Ingredients ▾
Inactive ingredients Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, PEG-12, Glycerin, Flavor, Hydrogen Peroxide, Sodium Lauryl Sulfate, Silica, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.
🎯 Purpose ▾
Purpose Anticavity
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.